Reducing Barriers to Care for Vulnerable Children With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)
研究概览
简要总结
The purpose of this study is to determine whether Problem-Solving Skills Training is effective in reducing barriers to health care and improving health-related quality of life for children with persistent asthma.
详细描述
Brief description: This 4-year research project will develop and test culturally and linguistically appropriate brief interventions to reduce barriers to health care for vulnerable children with persistent asthma.
Background: The U.S. health system presents formidable challenges to the timely receipt of high quality care, especially for vulnerable children (e.g., those in families of color, lower SES, limited English ability). This population is at greatest risk for poor health outcomes. Children with asthma are an important vulnerable subgroup. Asthma, with an estimated prevalence of 6.9%, is the most common chronic condition in children. It is the most frequent reason for pediatric hospitalization and is a condition with documented disparities in care outcomes.
A promising strategy for overcoming the barriers to quality care that these children encounter is the use of care coordinators who educate parents and children, connect the family with needed resources, and coordinate care from different settings. Care coordination has been shown effective in improving receipt of appropriate asthma services and health outcomes for children with asthma. Despite this evidence, there is concern that the effects of care coordination may not be maintained once these services end. This is particularly important given financial pressures to reduce the length and intensity of such services. In order to maintain the gains achieved during care coordination, families need to be able to identify and overcome barriers to care for and by themselves. This can be achieved through the use of Problem Solving Therapy, a documented behavioral method for teaching families the skills they need to resolve daily problems and improve adherence to medical regimens for children with chronic health conditions.
Study Goals: The overall goal of this project is to improve the quality of care and health outcomes for vulnerable children with asthma. The specific aims of this two-phase project are:
- (Phase I) to adapt, in collaboration with community health workers and parents, existing materials to create two culturally and linguistically appropriate treatment manuals: a Care Coordination Treatment Manual that will standardize the delivery of culturally and linguistically appropriate home-based care coordination and asthma-specific education, and a Problem Solving Therapy Treatment Manual tailored to asthma that will include a detailed, step-by-step guide for implementing this approach to reduce barriers to care.
- (Phase II) to use the manuals developed in Phase I to perform a randomized controlled clinical trial to evaluate the effectiveness of two brief interventions involving Care Coordination and tailored Problem Solving Therapy (tPST) in improving and maintaining improvement in health care quality and health-related quality of life for children with asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child age 2 to 12 years old, inclusive
- •Diagnosis of persistent asthma (mild, moderate, or severe) according to NHLBI criteria
- •Family speaks English or Spanish
排除标准
- •Family does not speak English or Spanish
- •Child has other comorbid conditions that would affect care or outcomes
研究组 & 干预措施
Problem solving + care coordination
Problem solving skills training and asthma care coordination
干预措施: Usual Care (Other)
Asthma care coordination
Asthma care coordination
干预措施: Asthma care coordination (Behavioral)
Asthma care coordination
Asthma care coordination
干预措施: Usual Care (Other)
Wait-list control
Usual care
干预措施: Usual Care (Other)
Problem solving + care coordination
Problem solving skills training and asthma care coordination
干预措施: Problem solving skills training (Behavioral)
Problem solving + care coordination
Problem solving skills training and asthma care coordination
干预措施: Asthma care coordination (Behavioral)
结局指标
主要结局
Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)
时间窗: Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)
The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, \& Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a 'problem' in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.
次要结局
- Counts of Patients With One or More Asthma-related Emergency Department Visits.(Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3))
- Asthma Symptoms(Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3))
